Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, Imaging, X-Ray, Electrostatic
510(k) Number K934949
Device Name DIGORA
Applicant
Orion Corporation Soredex
Nilsiankatu 10-14
Helsinki,  FI FIN-00510
Applicant Contact KAI LANER
Correspondent
Orion Corporation Soredex
Nilsiankatu 10-14
Helsinki,  FI FIN-00510
Correspondent Contact KAI LANER
Regulation Number892.1630
Classification Product Code
IXK  
Date Received10/18/1993
Decision Date 02/10/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-